Russia’s Sputnik V vaccine is 92% effective at protecting people from COVID-19 according to interim trial results, the country’s sovereign wealth fund said, as Moscow rushes to keep pace with Western drugmakers in the race for a shot. Russia’s results are only the second from a late-stage human trial, following on swiftly from data released on Monday by Pfizer Inc and BioNTech, which said their shot was also more than 90% effective.
“The use of the vaccine and the results of clinical trials demonstrate that it is an efficient solution to stop the spread of coronavirus infection, preventive health care tool, and this is the most successful path to defeat the pandemic,” Mikhail Murashko, Minister of Health of the Russian Federation, said in the release.
While Pfizer’s interim data was collected from over 43,500 participants, the Sputnik V findings have come from an evaluation of some 16,000 participants, a spokesperson for the Russian Direct Investment Fund (RDIF) said. The Russian sovereign wealth fund has partnered with Dr Reddy’s to test the vaccine in India for approvals here.
Russian President Vladimir Putin announced his country’s approval of Sputnik V in August. However, little data on the vaccine were made available, making experts wary of the vaccine’s effectiveness. At that time, former FDA commissioner Scott Gottlieb, MD, noted that Russia’s vaccine approval process is not on par with that of the United States.
In India, Dr Reddy’s is expected to test this vaccine candidate on around 1,500 participants in a phase 2/3 clinical trial across at least 10 sites. On October 28, the company had said during an earnings call that enrollment for the trial would begin within days.A source close to the development said the vaccination was yet to begin.
The Russian drug is named Sputnik V after the Soviet-era satellite that triggered the space race, a nod to the project’s geopolitical importance for Russian President Vladimir Putin. The vaccine is designed to trigger a response from two shots administered 21 days apart, each based on different viral vectors that normally cause the common cold: human adenoviruses Ad5 and Ad26. The Pfizer and BioNTech vaccine uses messenger RNA (mRNA) technology and is designed to trigger an immune response without using pathogens, such as actual virus particles. Russia is also testing a different vaccine, produced by the Vector Institute in Siberia, and is on the cusp of registering a third, Putin said on Tuesday, adding that all of the country’s vaccines were effective. RDIF said as of November 11 no serious side effects had been reported during the Sputnik V Phase III trial. Some volunteers had short-term minor adverse effects such as pain at the injection site, flu-like symptoms including fever, weakness, fatigue, and headaches, it said.